China, Taiwan Begin Shift to Regulatory Convergence

In a momentous first for both countries, regulatory officials from China and Taiwan sat down at the same table on Tuesday and discussed their relatively similar ideas around the regulation of drug approvals.

Although neither side acknowledged the other until the final question of the Q&A after four presentations from their respective Centers for Drug Evaluation (CDE), both sides shook hands afterwards and seemed open to further discussion.

In the final question of the session on regulatory science at DIA’s 49th annual meeting in Boston, Ling Su, former DIA president, asked both sides if China’s recent decision to approve a drug based on early phase data from Taiwan and late-phase data from China might be a sign of increasing developments.

Yi Feng of the Office of Evaluation Management and Communication in China’s CDE said the recent unnamed drug’s approval was not an outlier and could be seen more in the future. Likewise, Hsin-Jung Lee of Taiwan’s CDE said the reverse could happen in her country.

Both countries’ regulators stressed the need for efficiency, transparency and clarity in the regulatory review processes.

Upcoming Changes for China

Meanwhile, the CFDA (China Food and Drug Administration) is looking to amend its regulations around IND (investigational new drug) submissions, according to Dr. Zhen Chen, deputy office director of China’s Office of New Drug Pharmaceutical science.

“The regulations for INDs need to be amended,” and it will happen in the near future to “provide a consistent approach” to the way that they are filed for the various types of pharmaceuticals, Dr. Chen said.

In addition, milestone meetings for sponsors may now be held with CFDA officials at the pre-IND, IND, end of Phase I, end of Phase II and NDA (new drug application) submission stages, Zheng said. He noted that sponsors, CROs, PIs and IRBs will be held accountable for risk management.

The changes to China’s regulations come as the number of local companies submitting INDs nearly doubled in the last three years as the number of multinational companies submitting INDs also more than doubled between 2005 and 2012.

Taiwan Pushing for Fast-Track

As the CFDA deals with a heavier load, Taiwan’s CDE is looking to bring more drugs to market more quickly. Last year was the first year that Taiwan approved a drug before either the US FDA (Food and Drug Administration) or the EMA (European Medicine Agency).

In 2012, Taiwan’s CDE approved 76% of the drug applications it received as drugs that have previously been approved by the US FDA with trials in Japan or one other Asian medical center are part of the lowest-risk IND review track and most easily approved, according to Lee.

Taiwan is also looking to encourage more local clinical trials as companies that provide such data in their applications can receive five years of market exclusivity, Lee said. In 2012, Taiwan approved registration trials in 26 days on average, she added.

Mey Wang, a reviewer in the division of new drugs for Taiwan’s CDE, added that the country is now using a data bank to review past approvals for similar classes of drugs or similar mechanisms when reviewing the approval for a new drug.

Only when an IND is for a biosimilar, botanical or new drug on the global market does Taiwan’s CDE consult with an advisory committee before deciding on whether to bring that drug to market.

And unlike Taiwan, China has yet to develop a pathway for biosimilar approvals, though China’s Feng said it will be “coming soon.”

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In a momentous first for both countries, regulatory officials from China and Taiwan sat down at the same table on Tuesday and discussed their relatively similar ideas around the regulation of drug approvals.